FDA 510(k)

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Numéro K : K152771 · 2016-06-17

Date de décision2016-06-17

Code produitKNS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K152771. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K152771.

When did SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long receive FDA 510(k) clearance?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long received FDA 510(k) clearance on 2016-06-17, under 510(k) number K152771.

Who is the listed applicant for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

The FDA 510(k) record lists Sumitomo Bakelite Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

The FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is KNS.

Essais cliniques associés

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Autres dossiers indiquant Sumitomo Bakelite Co., Ltd. en tant que demandeur

K182520Flexible Overtube K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Dispositifs connexes (Code : KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Source officielle

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